FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY).
The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen.
FDA also granted priority review to the application.
In 2019, Enhertu first won FDA approval for HER2-positive unresectable or metastatic breast cancer after two or more prior anti-HER2-based regimens.
Two years later, the agency extended approval to patients with previously-treated HER2-positive advanced gastric cancer.
The recent application includes data from the DESTINY-Breast03 study,
That study found that Enhertu demonstrated a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla) in second-line HER2-positive unresectable or metastatic breast cancer. The study showed the drug was associated with a 72% reduction in the risk of disease progression or death compared to T-DM1.
The Prescription Drug User Fee Act (PDUFA) date is slated for the second quarter of the year.
Trastuzumab deruxtecan has been the focus of 59 clinical trials.
DSNKY shares ticked down 1.12% to $22.98 while AZN shares were up 1.68% to $59.84.